Asset profile

ACI-35.030

Vaccine

Phase 1/2Tau (monoclonal antibody)No recent registered activity
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Partialdesign only

Evidence outlook · no controlled comparison

NCT04445831 · Alzheimer's Disease, Cognitive Impairment, Tauopathies, Mild Cognitive Impairment,...

The lead study's design has limits that temper confidence (see the rationale below), and it produced no formal comparison against a control. This tier describes the design, not an outcome.

NCT04445831: This was a randomized, quadruple-blinded, placebo-controlled study, which is a strong design foundation, but the enrollment was very small (57 participants split across seven arms, several with only 4-6 subjects), and the primary endpoints were safety/tolerability counts and antibody-titer levels rather than a hard clinical or cognitive outcome - cognitive and functional scales (CDR-SB, RBANS, NPI) were only exploratory and their results were not even posted. Because the primary comparisons here are immunogenicity/safety readouts rather than a statistically tested clinical efficacy endpoint, this evidence is real but limited.

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Competitive landscape

67 competitors in this universe: 7 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 65 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
ACI-35.030: this drugPhase 1/2VaccineTau (monoclonal antibody)
NIO752Phase 3RNA / oligonucleotideTau (monoclonal antibody)
EtalanetugPhase 2/3Monoclonal antibodyTau (monoclonal antibody)
AADvac1Phase 2VaccineTau (monoclonal antibody)
BepranemabPhase 2Monoclonal antibodyTau (monoclonal antibody)
BMS-986446Phase 2Monoclonal antibodyTau (monoclonal antibody)
VY7523Phase 1/2Monoclonal antibodyTau (monoclonal antibody)
APNmAb005Phase 1Monoclonal antibodyTau (monoclonal antibody)
Benzgalantamine (Zunveyl)ApprovedSmall moleculeAcetylcholinesterase/nicotinic receptor (prodrug)
Brexpiprazole (Rexulti)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Dextromethorphan / Bupropion (Auvelity)ApprovedSmall moleculesigma-1/NMDA
Donanemab (Kisunla)ApprovedMonoclonal antibodyAmyloid-beta (monoclonal antibody)
Lecanemab (Leqembi)ApprovedMonoclonal antibodyAmyloid-beta (monoclonal antibody)
Xanomeline / Trospium Chloride (Cobenfy)ApprovedSmall moleculeMuscarinic M1/M4 receptor (agonist/antagonist combination)
ACP-204Phase 3Small moleculeSerotonin 5-HT2A receptor (antagonist / inverse agonist)
AR1001Phase 3Small moleculePDE5

…and 52 more. Research shows the complete landscape.

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Unlock the full comparison

Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Compare head-to-head

1 further head-to-head pair is tracked; the rosters on each shared mechanism and indication page list every rival in the race.

Upcoming events

No upcoming readouts on record for this asset.

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.